Radial Artery Assessment in Surgical Coronary Revascularisation

NCT06433960 | Completed

• 1 other identifier: 24/SC/0076
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to learn about how screening tests inform the radial artery (RA) suitability for harvesting and coronary bypass grafting in adults with ischaemic heart disease. The main question it aims to answer is:

• What factors influence the diagnostic accuracy of RA screening in patients undergoing surgical coronary revascularisation? Participants will:
• Receive an assessment of their RA through routinely used techniques (Modified Allen Test +/- pulse-oximetry, Barbeau Test and Ultrasound examination)
• Answer a symptoms scale about their physical experience after surgery

Conditions

Coronary Artery Bypass Grafting; Coronary Artery Disease

Keywords

Radial Artery; Modified Allen Test; Barbeau Test; Ultrasonography

Outcome Measures

Primary Outcomes (3)

• Sensitivity of Radial Artery Assessment Techniques

  Measure the sensitivity of the Modified Allen test (+/- pulse-oximetry), the Barbeau Test and ultrasonography examination.

  From enrollment to the end of treatment at 12 weeks.

• Specificity of Radial Artery Assessment Techniques

  Measure the specificity of the Modified Allen test (+/- pulse-oximetry), the Barbeau Test and ultrasonography examination.

  From enrollment to the end of treatment at 12 weeks.

• Negative and Positive predictive values of Radial Artery Assessment Techniques

  Measure the negative and positive predictive values of the Modified Allen test (+/- pulse-oximetry), the Barbeau Test and ultrasonography examination.

  From enrollment to the end of treatment at 12 weeks.

Secondary Outcomes (2)

• Radial Artery Quality Evaluation

  From enrollment to surgical harvesting of the radial artery at day 1-2 after hospitalisation.

• Patients Physical Experience Evaluation

  From day of surgery to the end of treatment at 12 weeks.

Study Arms (1)

Cardiovascular sample group

Cardiac patients undergoing elective or urgent coronary artery bypass graft surgery and radial artery harvest in two Cardiothoracic hospitals.

Diagnostic Test: Modified Allen Test; Diagnostic Test: Pulse-oximetry guided Modified Allen Test; Diagnostic Test: Barbeau Test; Diagnostic Test: Ultrasound examination of the forearm arteries; Diagnostic Test: Measurement of oxygen saturation; Other: Radial Artery Quality Evaluation Survey; Other: Follow-up Radial Artery Harvesting Scale

Interventions

Modified Allen Test DIAGNOSTIC_TEST

Pre-operative intervention aimed at evaluating if forearm blood vessels (ulnar artery and collateral) would supply an adequate blood flow to the arm if the radial artery was harvested. Duration: 1 minute. Instruct the patient to clench their wrist while the examiner occlude with three fingers the patients ulnar and radial arteries; instruct the patient to unclench their wrist; release the ulnar artery. The MAT result is negative or positive considering in how long the palm flushes: ≤5 seconds: negative MAT; good collateral hand circulation (suggesting harvestable radial artery). greater than 5 seconds: positive MAT; poor collateral hand circulation (suggesting not-harvestable radial artery).

Cardiovascular sample group

Pulse-oximetry guided Modified Allen Test DIAGNOSTIC_TEST

Pre-operative intervention aimed at evaluating if forearm blood vessels (ulnar artery and collateral) would supply an adequate blood flow to the arm if the radial artery was harvested. Duration: 1 minute. A pulse-oximetry probe is positioned on the patients index finger; both radial and ulnar arteries are occluded by the examiner (with three fingers) until flattening of pulse waveform is obtained. Pressure on the ulnar artery is released and the result of the assessment is calculated considering in how long the pulse waveform returns to baseline: ≤5 seconds: negative result (suggesting harvestable radial artery). greater than 5 seconds: positive result (suggesting not harvestable radial artery). (Busti and Kellogg, 2015)

Cardiovascular sample group

Barbeau Test DIAGNOSTIC_TEST

Pre-operative intervention aimed at evaluating if forearm blood vessels (ulnar artery and collateral) would supply an adequate blood flow to the arm if the radial artery was harvested. Duration: 2 minutes. A pulse-oximetry probe is positioned on the patients thumb; the radial artery is then compressed by the examiner, and the pulse waveform is analysed for up to 120 seconds, providing four result patterns of ulno-palmar patency: 1. No damping of the pulse tracing immediately after compression (suggesting harvestable radial artery) 2. Damping of the pulse tracing (suggesting harvestable radial artery) 3. Loss of the pulse tracing, followed by recovery within 120 sec (suggesting harvestable radial artery) 4. Loss of the pulse tracing, without recovery within 120 sec (suggesting not harvestable radial artery). (Zalocar et al., 2020)

Cardiovascular sample group

Ultrasound examination of the forearm arteries DIAGNOSTIC_TEST

Pre-operative intervention aimed at evaluating morphological characteristics (diameter, presence of calcifications) of the radial and ulnar arteries. Duration: 5 minutes. The radial artery is surgically exposed (negative result) when the following apply: 1. ulnar artery inner diameter ≥2 mm 2. radial artery inner diameter ≥2 mm 3. absence of radial artery intraluminal calcifications and plaques. (Vukovic et al., 2017)

Cardiovascular sample group

Measurement of oxygen saturation DIAGNOSTIC_TEST

Intra-operative intervention aimed at evaluating the blood oxygen level in the hand if the radial artery was harvested. Duration: 1 minute. The radial artery is surgically harvested when the oxygen saturation reading (SpO2) from the thumb through pulse-oximetry remains at 95% or above when an occlusive atraumatic clamp is applied on the mobilised radial artery.

Cardiovascular sample group

Radial Artery Quality Evaluation Survey OTHER

Intra-operative intervention (validated structured questionnaire) aimed at evaluating anatomical and physiological characteristics of the radial artery and suitability for coronary graft implantation. The radial artery is surgically harvested when its morphology and pathology (diameter, calcifications, presence of pulsatile flow), quality of harvesting technique and surgical accessibility are considered satisfactory, good or optimal. The Radial Artery Quality Evaluation Survey is completed by surgical care practitioners.

Cardiovascular sample group

Follow-up Radial Artery Harvesting Scale OTHER

Postoperative intervention (ordinal symptoms scale) aimed at evaluating patients finger movements, cold tolerance sensitivity and tactile/touch perception at post-operative day 2 to 5 and at follow-up appointment (3-6 weeks after surgery). Bilateral comparison between hands and forearms is undertaken. Tactile perception is assessed through monofilaments (single touch). Cold sensitivity is assessed through the use of ice-pack. The Follow-up Radial Artery Harvesting Scale was developed from a verbal rating scale (VRS) questionnaire documented in the literature. The VRS questionnaire was re-adapted to appreciate people postoperative experience with their finger movements, cold sensitivity and tactile/touch perception of their forearm.

Cardiovascular sample group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with ischaemic heart disease undergoing coronary bypass surgery and radial artery harvest at Royal Papworth and Royal Brompton hospitals will be invited to participate in this study.

You may qualify if:

• Male and female adults patients undergoing elective or urgent coronary artery bypass graft (CABG) surgery and radial artery (RA) harvesting in two Cardiothoracic hospitals.

You may not qualify if:

• Paediatric patients and/or adult patients undergoing emergency CABG will not be considered within the participants of this cross-sectional study, as well as patients lacking capacity to consent and non-English speaking patients requiring use of interpreters. Patients not wishing to participate in the study will also not be recruited.

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

Study Sites (2)

Royal Brompton Hospital

London, England, SW3 6NP, United Kingdom

Location

Royal Papworth Hospital

Cambridge, England/Cambridgeshire, CB20AY, United Kingdom

Location

Related Publications (2)

• Zalocar LAD, Doroszuk G, Goland J. Transradial approach and its variations for neurointerventional procedures: Literature review. Surg Neurol Int. 2020 Aug 15;11:248. doi: 10.25259/SNI_366_2020. eCollection 2020.

  PMID: 32905334 BACKGROUND

• Vukovic P, Peric M, Radak S, Aleksic N, Unic-Stojanovic D, Micovic S, Stojanovic I, Milojevic P. Preoperative Insight Into the Quality of Radial Artery Grafts. Angiology. 2017 Oct;68(9):790-794. doi: 10.1177/0003319716686014. Epub 2017 Jan 5.

  PMID: 28056520 BACKGROUND

Related Links

• Busti, A.J. and Kellogg, D. (2015) Allens Test.
• Kinoue, T. and Arai, M. (2021) Comparison of Rating Scale Methods for Cold Sensation in Kampo Medicine, International Medical Journal, 28(1), pp.94-97.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Vincenzo De Franco, MSc SCP

  Royal Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: July 10, 2024
• Primary Completion: January 8, 2025
• Study Completion: March 31, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months and ending 3 years after the publication of results.
• Access Criteria: Researchers wishing to conduct a diagnostic accuracy analysis of the tests (interventions) under investigation car require copy of the anonymised IPD and supporting information to the principal investigator. A proposal describing the planned analysis must be provided and a data sharing agreement form (requested to the sponsoring institution) must be signed. Further instructions for obtaining access are available at the link below: https://royalpapworth.nhs.uk/research-and-development or contacting: papworth.randdadmin@nhs.net

Locations

GB (2)